2. What should I know before I use Lecteva?
Do not use if you have ever had an allergic reaction to levodopa, carbidopa or entacapone
or any of the ingredients listed at the end of the CMI. Contains lactose.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Lecteva and affect how it works.
4. How do I use Lecteva?
People with moderate to severe Parkinson’s disease usually take from 3 to 7 tablets
of Lecteva each day; maximum daily dose depends on the tablet strength.
Take only one Lecteva tablet at each dose.
Do not take 2 or more Lecteva tablets at any one time. Do not break the tablets into
halves.
5. What should I know while using Lecteva?
|
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you are using Lecteva.
If you become pregnant, your doctor immediately. You should not take this medicine
while you are pregnant.
Visit your doctor regularly so they can check on your progress.
|
|
Things you should not do
|
Do not stop using this medicine or reduce the dose suddenly without talking to your
doctor.
|
|
Driving or using machines
|
Be careful driving, operating machinery or doing jobs that require you to be alert
while you are taking Lecteva until you know how it affects you.
|
|
Looking after your medicine
|
Store below 25°C.
|
6. Are there any side effects?
Common side effects: nausea (feeling sick), vomiting, diarrhoea, pain in the stomach, constipation, dizziness,
light-headedness, extreme sleepiness and sudden onset of sleep and unusual and uncontrollable
twitching, jerking or writhing movements, muscle and/or joint pain.
Severe side effects: compulsive behaviours, confusion, chest pain/tightness, shortness of breath or difficulty
breathing and fast or irregular heartbeats.
Active ingredient(s):
Levodopa/carbidopa monohydrate/entacapone
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Lecteva. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Lecteva.
Where to find information in this leaflet:
1. Why am I using Lecteva?
Lecteva contains the active ingredients levodopa, carbidopa monohydrate and entacapone. Lecteva is an anti-Parkinson medicine containing dopaminergic agents that work together
to increase the level of dopamine in the brain.
Lecteva is used to treat the symptoms of Parkinson’s disease, such as shaking of the limbs, stiffness and slowness of movement, which make it difficult
to perform normal daily activities.
Parkinson’s disease is a disorder of the nervous system. It is caused by a lack of
dopamine, a natural substance that is produced in the brain.
Other medicines can also help to treat this condition.
2. What should I know before I use Lecteva?
Warnings
Do not use Lecteva if:
You are allergic to levodopa, carbidopa or entacapone, or any of the ingredients listed
at the end of this leaflet. Always check the ingredients to make sure you can use
this medicine.
You are taking a medicine called a monoamine oxidase inhibitor (MAOI) such as phenelzine
and tranylcypromine.
You are pregnant.
You are breastfeeding.
You have a problem with your liver.
You have a tumour of the adrenal gland (called phaeochromocytoma) which could cause
your blood pressure to rise to a dangerous level.
You have ever had a serious condition called neuroleptic malignant syndrome (NMS),
with symptoms such as a sudden increase in body temperature, sweating, fast heartbeat,
muscle stiffness and fluctuating blood pressure.
You have ever had a condition called non-traumatic rhabdomyolysis, with symptoms of
severe muscle weakness that was not due to an injury.
You have unusual skin lumps or moles which have not been examined by your doctor,
or if you have ever had skin cancer or melanoma.
You have a type of glaucoma called narrow-angle glaucoma.
It is after the expiry date printed on the pack or if the packaging is torn or shows
signs of tampering.
If you are not sure whether any of the above conditions apply to you, your doctor
can advise you.
Ask your doctor or pharmacist if you are not sure if you have been taking one of these
medicines.
Check with your doctor if you:
Have depression, mental disturbances, or you recognise anti-social behaviour
Have heart disease, including irregular heartbeat, also known as arrhythmia
Have kidney problems
Have lung problems including asthma
Have hormonal problems
Have convulsions or fits
Have a type of glaucoma called wide angle glaucoma
Have stomach ulcers
Have problems with your gall bladder
Have inflammatory bowel disease
Have an intolerance to lactose
Have allergies to any other medicines, foods, dyes or preservatives
Your doctor may need to adjust the dose of Lecteva in some of these cases.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Do not take Lecteva if you are pregnant. Tell your doctor immediately if you become
pregnant. There is not enough information to recommend using Lecteva during pregnancy.
Do not take Lecteva if you are breastfeeding.
It is not known if the active ingredients in Lecteva pass into breast milk and could
affect your baby. Talk to your doctor if you are breastfeeding or intend to breastfeed.
Use in children under 18 years
Lecteva should not be used in children under the age of 18 years. The safety of Lecteva
and how well it works has not be studied in children younger than 18 years of age.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some medicines may interfere with Lecteva and affect how it works. These include:
monoamine oxidase inhibitor (MAOI) such as phenelzine and tranylcypromine. Taking
Lecteva together with some, but not all, MAOI medicines may cause a serious reaction
with a sudden increase in body temperature, extremely high blood pressure and severe
convulsions. Your doctor will know whether or not the MAOI medicine you are taking
can be safely taken with Lecteva.
dopamine D2 receptor antagonists such as phenothiazines, butyrophenones, risperidone
and isoniazid.
some antibiotics such as erythromycin, rifampicin, ampicillin and chloramphenicol.
apomorphine, a medicine used in Parkinson's Disease.
adrenaline, a medicine used in some local anaesthetics and in emergency treatment
of allergic reactions.
cholestyramine, a medicine used to reduce high levels of cholesterol in the blood.
papaverine, a medicine used to expand blood vessels to treat men with erectile dysfunction.
probenecid, a medicine used to prevent gout.
some medicines used to treat high blood pressure.
other medicines for Parkinson's disease.
some medicines for depression.
some medicines for psychiatric disorders.
methyldopa, a medicine for high blood pressure.
isoniazid, a medicine used to treat tuberculosis.
some medicines for nausea and vomiting.
phenytoin, a medicine used to treat convulsions.
medicines containing iron, such as iron tablets or multiple vitamins.
warfarin, a medicine used to prevent blood clots.
You may need to take a different amount of your medicines or to take different medicines
while you are taking Lecteva. Your doctor and pharmacist have more information.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Lecteva.
4. How do I use Lecteva?
How much to take
People with moderate to severe Parkinson’s disease usually take from 3 to 7 tablets
of Lecteva each day.
For Lecteva 50/12.5/200 mg, 75/18.75/200 mg, 100/25/200 mg, 125/31.25/200 mg and 150/37.5/200
mg strengths the maximum dose is 10 tablets each day.
For Lecteva 175/43.75/200 mg strength, the maximum dose is 8 tablets each day.
For Lecteva 200/50/200 mg strength, the maximum dose is 7 tablets each day.
Take only one Lecteva tablet at each dose.
Do not take 2 or more Lecteva tablets at a time.
How to take Lecteva
Take the tablet with a full glass of water.
Do not break the tablets into halves.
If your stomach is upset after taking the tablet, take it with a meal or after a snack.
It does not matter if you take Lecteva with or without food but avoid a high protein
meal.
If you are taking any medicines containing iron, take them at least 2 or 3 hours before
or after a dose of Lecteva. If you take the two medicines at the same time, your body
may absorb less iron than usual.
How long to take Lecteva
Do not stop taking this medicine without first checking with your doctor. You may
need to take Lecteva for a long time to control your symptoms. If you stop taking
it, the dose of your other medicines for Parkinson’s disease may have to be increased
to prevent your symptoms from getting worse.
If you forget to take Lecteva
Lecteva should be used regularly at the same time each day. If you miss your dose
at the usual time, you should take it as soon as you notice that you have forgotten
to take your medication.
If it is almost time for your next dose (say, within an hour of the next dose), skip
the dose you missed and take your next dose when you are meant to.
Do not take a double dose to make up for forgotten individual doses. This may increase
the chance of you getting unwanted side effects.
If you have trouble remembering when to take your medicine, ask your pharmacist for
some hints.
If you use too much Lecteva
If you think that you have used too much Lecteva, you may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using Lecteva?
Things you should do
If you experience times where Lecteva does not appear to be working as well as it
did previously, tell your doctor.
If you become pregnant, tell your doctor immediately. You should not take this medicine
while you are pregnant.
Before having any surgery or other hospital treatment, tell the anaesthetist or the
doctor that you are taking Lecteva. It may cause unwanted side effects if you take
it at the same time as some medicines that are used in hospital.
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are taking Lecteva.
Be sure to keep all of your doctor's appointments so that your progress can be checked.
Your doctor may also want to take some tests from time to time to help prevent unwanted
side effects.
Tell your doctor if you or your family/carer notices you are developing addiction-like
symptoms leading to craving for large doses of Lecteva and other medicines used to
treat Parkinson’s disease (known as dopamine dysregulation syndrome).
Tell your doctor if you or your family/caregiver notices you are developing urges
or cravings to behave in ways that are unusual for you or you cannot resist the impulse,
drive or temptation to carry out certain activities that could harm yourself or others.
These behaviours are called impulse control disorders and can include addictive gambling,
excessive eating or spending, an abnormally high sex drive or a preoccupation with
an increase in sexual thoughts or feelings. Your doctor may need to review your treatments.
Remind any doctor, dentist or pharmacist you visit that you are using Lecteva.
Things you should not do
Do not give this medicine to anyone else, even if their condition seems similar to
yours.
Do not use it to treat any other complaints unless your doctor tells you to.
Do not reduce the dose or stop treatment abruptly without consulting your doctor.
It may be necessary to reduce the dose of Lecteva gradually in order to prevent side
effects.
Things to be careful of
If this medicine makes you feel light-headed, dizzy or faint, be careful when getting
up from a sitting or lying position. These symptoms may be a sign of low blood pressure. You can usually prevent them
by getting up slowly and flexing leg muscles and toes to get the blood flowing. When
getting out of bed, dangle your legs over the side for a minute or two before standing
up.
Be careful not to eat a diet high in protein. The amount of levodopa absorbed by the body may be impaired if you eat a diet high
in protein. Ask your doctor, pharmacist or dietician to check your diet.
Driving or using machines
Be careful before you drive or use any machines or tools or doing jobs that require
you to be alert until you know how Lecteva affects you.
This medicine may increase the dizziness, light-headedness or sleepiness that sometimes
happens when you take levodopa. Very rarely it can cause extreme sleepiness and sudden
onset of sleep in the middle of daytime activities, sometimes without warning.
If you have any of these symptoms, do not drive or do anything else that could be
dangerous.
Looking after your medicine
Keep your medicine in the original container until it is time to take it.
Follow the instructions in the carton on how to take care of your medicine properly.
Store it in a cool dry place away from moisture, heat or sunlight and below 25°C;
for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it. A locked cupboard at least one-and-a-half
metres above the ground is a good place to store medicines.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
Serious side effects
|
Serious side effects
|
What to do
|
|
Allergy related
rash, itching or hives on the skin
Mental states of behaviour related
worsening of your symptoms of Parkinson’s disease
confusion or hallucinations (seeing, hearing or feeling things that are not there)
craving for large doses of Lecteva in excess of that required to control motor symptoms,
known as dopamine dysregulation syndrome. Some patients experience severe uncontrolled
movements (dyskinesias), mood swings, or other side effects after taking large doses
of Lecteva.
inability to resist the impulse to perform an action that could be harmful, which
may include:
strong impulse to gamble excessively despite serious or personal family consequences
altered or increased sexual interest and behaviour of significant concern to you or
to others, for example an increased sexual drive
uncontrolled excessive shopping or spending
binge eating (eating large amounts of food in a short time period) or compulsive eating
(eating more food than normal and more than is needed to satisfy your hunger)
medication use
repetitive purposeless activities
Heart or blood pressure related
difficulty breathing, congestion in the chest, chest pain
Signs of possible anemia (low amount of iron in your blood)
tiredness, headaches, shortness of breath when exercising, dizziness and looking
pale
Signs of possible liver problems
loss of appetite, feeling generally unwell, fever, itching, yellow colour to the
skin and eyes
Stomach, bowel or urinary related
gastrointestinal bleeding (coughing up blood or blood in the stools)
diarrhoea, usually with blood and mucus
Others
symptoms of neuroleptic malignant syndrome, such as a sudden increase in body temperature,
sweating, fast heartbeat, muscle stiffness and fluctuating blood pressure
temporary paralysis or weakness of muscles
fever
|
Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects or experience any
of these behaviours.
Your doctor will discuss ways of managing or reducing the symptoms.
|
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Lecteva contains
|
Active ingredients
(main ingredients)
|
Each tablet contains:
50, 75, 100, 125, 150, 175 or 200 mg of levodopa and,
12.5, 18.75, 25, 31.25, 37.5, 43.75 or 50 mg of carbidopa and,
200 mg of entacapone
|
|
Other ingredients
(inactive ingredients)
|
microcrystalline cellulose
lactose
hyprolose
hypromellose
povidone
colloidal anhydrous silica
magnesium stearate
titanium dioxide
glycerol
polysorbate 80
50/12.5/200 mg strength
iron oxide yellow
iron oxide red
iron oxide black
75/18.75/200 mg strength
iron oxide yellow
iron oxide red
100/25/200 mg strength
allura red AC aluminium lake
carmine
125/31.25/200 strength
iron oxide yellow
iron oxide red
150/37.5/200 mg strength
iron oxide red
carmoisine aluminium lake
175/43.75/200 mg strength
iron oxide yellow
iron oxide red
iron oxide black
200/50/200 mg strength
iron oxide yellow
iron oxide red
iron oxide black
|
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Potential allergens
|
Sugars (as lactose)
|
Do not take this medicine if you are allergic to any of these ingredients.
What Lecteva looks like
Lecteva 50/12.5/200 mg are round, light brown, marked with “50” on one side and plain
on the other (AUST R 238860)
Lecteva 75/18.75/200 mg are oval, light orange, marked with “75” on one side and plain
on the other (AUST R 238861)
Lecteva 100/25/200 mg are oblong, pale red, marked with “100” on one side and plain
on the other (AUST R 238862)
Lecteva 125/31.25/200 mg are round, yellowish brown, marked with “125” on one side
and plain on the other (AUST R 238863)
Lecteva 150/37.5/200 mg are oval, dark red, marked with “150” on one side and plain
on the other (AUST R 238864)
Lecteva 175/43.75/200 mg are ellipse, pale brown, marked with “175” on one side and
plain on the other (AUST R 238865)
Lecteva 200/50/200 mg are oblong, brown, marked with “200” on one side and plain on
the other (AUST R 238866)
All strengths are supplied in HDPE bottles.
Who distributes Lecteva
Teva Pharma Australia Pty Ltd
Level 1, 37 Epping Road
Macquarie Park NSW 2113
Ph: 1800 288 382
This leaflet was prepared in November 2025.